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MAROL 150MG PROLONGED-RELEASE TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE

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TEVA UK Ref:

231-30-87197-X LEA TRAMADOL (MAROL) A/S TAB TUK XMOR

Version:

1

5 June 2014

tablets, antidepressants, some other pain killers);
• other opioid pain killers (analgesics) (such as
buprenorphine, nalbuphine or pentazocine);
(Tramadol hydrochloride)
• carbamazepine (for epilepsy);
PACKAGE LEAFLET: INFORMATION FOR THE USER • antidepressant or antipsychotic medicines (such as
fluoxetine, citalopram, amitriptyline, imipramine,
Read all of this leaflet carefully before you start taking
chlorpromazine, haloperidol or sulpiride);
this medicine.
• medicines to thin the blood (such as warfarin);
• Keep this leaflet. You may need to read it again.
• ketoconazole (a medicine for treating fungal infections);
• If you have any further questions, ask your doctor or
• erythromycin (an antibiotic for treating infections).
pharmacist.
The risk of side effects increases,
• This medicine has been prescribed for you. Do not
• if you are taking medicines which may cause
pass it on to others. It may harm them, even if their
convulsions (fits), such as certain antidepressants or
symptoms are the same as yours.
antipsychotics. The risk of having a fit may increase if
• If any of the side effects get serious, or if you notice
you take Marol tablets at the same time. Your doctor
any side effects not listed in this leaflet, please tell
will tell you whether Marol tablets are suitable for you.
your doctor or pharmacist.
• if you are taking certain antidepressants. Marol tablets
IN THIS LEAFLET:
may interact with these medicines and you may
experience symptoms such as involuntary, rhythmic
1. What Marol Tablets are and what they are used for
contractions of muscles, including the muscles that
2. Before you take Marol Tablets
3. How to take Marol Tablets
control movement of the eye, agitation, excessive
4. Possible side effects
sweating, tremor, exaggeration of reflexes, increased
5. How to store Marol Tablets
muscle tension, body temperature above 38°C.
6. Further information
Taking with food and drink
Marol tablets can be taken before, with or after food. You
MAROL TABLETS ARE AND WHAT THEY should NOT drink alcohol whilst taking these tablets.
1 WHAT
ARE USED FOR
Pregnancy and breast-feeding
The name of your medicine is Marol 100 mg, 150 mg or
Marol tablets should not be taken during pregnancy as it
200 mg Prolonged-release Tablets.
may affect the unborn child. If you become pregnant while
Each prolonged release tablet contains 100 mg, 150 mg
taking Marol you should talk to your doctor immediately.
or 200 mg of tramadol hydrochloride. Tramadol, the
It is also not advised to take the tablets whilst
active substance, is a centrally acting opioid analgesic
breast-feeding. However, if your doctor feels it necessary,
that is used for the treatment of moderate to severe pain.
you do not have to stop breast-feeding for a once only
Marol Prolonged-release tablets are referred to as Marol
dose of Marol Tablets.
tablets below.
Driving and using machines
Marol tablets can affect your ability to drive and operate
2 BEFORE YOU TAKE MAROL TABLETS
machinery, particularly when combined with other
medicines that can cause drowsiness. Therefore, driving
Do not take Marol Tablets
and operating machinery is not advised whilst taking
• if you are allergic (hypersensitive) to tramadol
hydrochloride or any of the other ingredients of Marol these tablets.
The medicine can affect your ability to drive as it may
Tablets
• if you are pregnant (see Pregnancy and breast-feeding make you sleepy or dizzy.
• Do not drive while taking this medicine until you know
below)
how it affects you.
• if you have recently drunk too much alcohol or taken
• It is an offence to drive if this medicine affects your
too many sleeping tablets, other pain killers or any
ability to drive.
medicines that affect your mood such as
• However, you would not be committing an offence if:
antidepressant medicines
• The medicine has been prescribed to treat a
• if you are, or have taken in the last two weeks, an
medical or dental problem and
antidepressant medicine called a monoamine oxidase
• You have taken it according to the instructions
inhibitor (MAOI), such as phenelzine or moclobemide.
given by the prescriber or in the information
Take special care with Marol Tablets if
provided with the medicine and
• you have recently had any head injuries, suffered from
• It was not affecting your ability to drive safely.
any severe headaches or felt sleepy for no reason
Talk to your doctor or pharmacist if you are not sure
(especially after an accident)
whether it is safe for you to drive while taking this
• you have recently had an accident where you may still medicine.
be in shock
• you find it difficult to breathe, or your breathing is a lot
3 HOW TO TAKE MAROL TABLETS
slower than normal
• you have, or have had, an addiction to opioid
Always take Marol tablets exactly as your doctor has told
analgesics (such as morphine, diamorphine or codeine) you. You should check with your doctor or pharmacist if
• you have epilepsy.
you are not sure. The tablets should be swallowed whole,
If any of the above apply to you, please talk to your doctor without breaking or chewing, with a glass of water. The
or pharmacist for advice if you have not already done so. usual dose is:Adults:
Taking other medicines
Please tell your doctor or pharmacist if you are taking or The usual starting dose is one 100 mg tablet twice a day
(in the morning and evening). If this is not sufficient to kill
have recently taken any other medicines, including
the pain, your doctor may give you either one 150 mg
medicines obtained without a prescription.
In particular, you should talk to your doctor before taking tablet or one 200 mg tablet twice a day.
The dosage should be adjusted to the intensity of your
Marol if you are taking any of the following:
pain and your individual pain sensitivity. In general the
• a monoamine oxidase inhibitor (MAOI) (such as
lowest pain-relieving dose should be taken. This is usually
isocarboxazid, phenelzine or tranylcypromine)
no more than 400 mg (two 200 mg tablets) a day except
• alcohol;
in special circumstances.
• medicines that cause drowsiness (such as sleeping

MAROL 100 mg, 150 mg and 200 mg
PROLONGED RELEASE TABLETS

TEVA UK Ref:

231-30-87197-X LEA TRAMADOL (MAROL) A/S TAB TUK XMOR

Marol tablets should not be used for any longer than is
absolutely necessary. If you need to take these tablets for
a long period your doctor will monitor you regularly.
Children (under 12 years old):
Marol tablets are not suitable for children under 12 years old.
Elderly patients:
In elderly patients (above 75 years) the excretion of
tramadol may be delayed. If this applies to you, your
doctor may recommend prolonging the dosage interval.
Severe liver or kidney disease (insufficiency)/dialysis
patients:
Patients with severe liver and/or kidney insufficiency should
not take Marol tablets. If in your case the insufficiency is
mild or moderate, your doctor may recommend
prolonging the dosage interval.
If you take more Marol Tablets than you should
Immediately contact your doctor or your nearest hospital
casualty department immediately. Please take any remaining
medicine with you in the carton in which it came so that
staff will know what has been taken.
If you forget to take Marol Tablets
Take it as soon as you remember then continue as before.
If it is nearly time for your next tablet, leave the missed
dose and continue as before. Do not take any more tablets
in one day than your doctor has prescribed. Do not take a
double dose to make up for a forgotten dose.
If you stop taking Marol Tablets
You may suffer from the following withdrawal effects when
you stop taking these tablets:
• agitation
• anxiety
• nervousness
• problems in sleeping
• feeling overactive
• shaking
• feeling sick or bloated, stomach pain or discomfort,
and similar stomach problems.
If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Marol Tablets can cause side effects,
although not everybody gets them.
Stop taking the tablets and tell your doctor immediately if
you experience any of the following rare effects:
• A severe or itchy skin rash, especially if this shows
blistering and there is soreness of the eyes, mouth or
genital organs
• Swelling of the hands, face, lips or tongue
• Difficulty in breathing, or wheezing.
These are all possible signs of a severe allergic reaction.
Very common side effects (affecting more than 10 people
in every 100) are nausea and dizziness.
Common side effects (affecting 1 to 10 people in every 100)
include:
• headache;
• drowsiness;
• being sick (vomiting);
• constipation;
• dry mouth;
• sweating.
Uncommon side effects (affecting less than 1 person in
every 100) include:
• being aware of your heartbeat (heart palpitations);
• heart beating faster than normal;
• dizziness or fainting when standing from a sitting or
lying position (hypotension);
• a collapse of the heart and blood supply;
• retching;
• a feeling of pressure or bloating in the stomach;
• skin reactions, such as itching or a rash, reddening of

Version:

1

5 June 2014

the skin.
Rare side effects (affecting less than 1 person in every
1000) include:
• slower heartbeat than normal;
• an increase in your blood pressure;
• changes in appetite;
• tingling of the hands and feet;
• shaking (tremor);
• breathing slower than normal;
• convulsions (fits);
• seeing or hearing things that are not there (hallucinations);
• confusion;
• sleep disturbances and nightmares;
• changes in your mood, such as feeling unusually
cheerful, or sometimes emotional and moody;
• changes in activity levels, this is usually feeling slower
but some people may feel more energetic;
• a change in how you see things (perception) or your
ability to make decisions;
• blurred vision;
• muscle weakness;
• difficulty in passing water;
• allergic reactions (see first warning above), you should
immediately stop taking the tablets and talk to your
doctor.
There have been a few isolated reports of an increase in
liver enzymes. This would only usually be seen after you
have had a blood test. Your doctor may check you for this,
if the doctor thinks it is necessary.
If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.

5

HOW TO STORE MAROL TABLETS

Keep out of the reach and sight of children.
Do not use Marol tablets after the expiry date which is
stated on the carton and also on the blister.
This medicinal product does not require any special
storage conditions.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment.

6

FURTHER INFORMATION

What Marol Tablets contain
• The active substance is Tramadol hydrochloride.
• The other ingredients are calcium hydrogen phosphate
dihydrate (E341), hydroxypropylcellulose (E463),
colloidal anhydrous silica (E551), and magnesium
stearate (E470b).
What Marol Tablets look like and contents of the pack
Marol 100 mg tablets are round, biconvex, off white,
prolonged release tablets.
Marol 150 mg and 200 mg tablets are capsule-shaped, off
white, prolonged release tablets.
All the strengths are available in either clear or opaque
coloured blister packs and pots of 10, 20, 30, 50, 60, 90, 100,
120, and 180 tablets but not all pack sizes may be marketed.
Marketing Authorisation Holder:
Morningside Healthcare Ltd.,
115 Narborough Road, Leicester, LE3 0PA, UK.
Manufacturers:
FAL Duiven, Dijkgraaf, 6921, RK Duiven, The Netherlands.
Medochemie Ltd, Facility A-Z, Ayios Athanassios,
Industrial Street, Limassol, Cyprus.
Morningside Pharmaceuticals Ltd
5 Pavilion Way, Loughborough, LE11 5GW, UK.
This leaflet was last revised in June 2014

87197-X

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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